FDA 510(k) Application Details - K955776

Device Classification Name	More FDA Info for this Device
510(K) Number	K955776
Device Name	ACU-LAB
Applicant	GLEDERER & CO., INC. 503 EAST 40TH ST. PATERSON, NJ 07504 US Other 510(k) Applications for this Company
Contact	GABE LEDERER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	LDQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/1995
Decision Date	06/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review